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LifeSphere Advanced Intake

Safety case intake automation using GenAI and LLMs to extract data from diverse sources and generate narratives with >90% accuracy.

Solution by ArisGlobal
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Overview

LifeSphere Advanced Intake is a safety case intake automation solution from ArisGlobal, designed for life sciences companies, CROs, and government health authorities involved in pharmacovigilance. It uses automation technologies including Generative AI (GenAI), large language models (LLMs), robotic process automation (RPA), and AI/ML to streamline the collection and processing of safety data from diverse sources.

The solution is built on an open architecture, allowing it to be deployed on top of existing safety databases and integrated with third-party safety systems without requiring replacement of current infrastructure. ArisGlobal reports that users can achieve up to 65% increased intake efficiency with greater than 90% data extraction accuracy based on real-world case results.

Core Capabilities

  • Case Intake and Triage: Provides production-ready automation across key case intake and triage activities to drive immediate efficiency gains.
  • Dynamic Data Extraction: Uses GenAI and LLMs to perform form-independent data extraction from safety cases, handling both structured and unstructured data with a focus on accuracy and data quality.
  • Narrative Generation: Applies LLMs to automatically generate detailed narratives based on existing case data and follow-up information.
  • EV Triage: Automates the triage and reconciliation of E2B (R3) cases from EVWEB bulk case downloads into a pharmacovigilance database, reducing the need for manual intervention.
  • Mobile Case Intake: Provides a mobile and web application for reporting adverse events and tracking submitted reports in real time, accessible from any location.
  • Literature Intake: Automates end-to-end literature monitoring, covering literature ingestion, data extraction, triage and classification, and literature surveillance.

Deployment and Integration

  • Designed to be system-agnostic, implementing case intake automation over existing safety databases via open architecture.
  • Supports integrations with third-party safety systems.
  • Offers an expedited deployment process supported by implementation experts and production-ready automation components.

Company Context

  • ArisGlobal collaborates with more than 220 global life sciences companies, CROs, and government health authorities, including regulatory bodies such as the FDA, Health Canada, and NMPA.
  • ArisGlobal is headquartered in the United States, with regional offices in Europe, India, Japan, and China.

LifeSphere Advanced Intake is positioned as a modular solution within ArisGlobal's broader GenAI-powered safety portfolio, intended to complement rather than replace existing pharmacovigilance infrastructure.

Meta

Domain
Regulatory & Safety Documentation
Subdomain
Pharmacovigilance & Drug Safety
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
QA / Regulatory AffairsMedical Affairs ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
GxPICH
Tag(s)
Uses AI